Evaluation of a Mind-body Education Program to Enhance Resiliency and Reduce Burnout in Residents

Resident Burnout Clinical Trial

Official title:

Evaluation of a Mind-body Education Program to Enhance Resiliency and Reduce Burnout in Residents

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02621801
• Other study ID #: 2015P000916
• Status: Active, not recruiting
• Phase: N/A
• First received: November 23, 2015
• Last updated: December 1, 2015
• Start date: August 2015
• Est. completion date: July 2016

Study information

• Verified date: December 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This prospective, waitlist-control study is evaluating the benefits of a stress management and resiliency training program for residents (SMART-R).

The primary aim of this study is to determine whether the SMART-R is effective at increasing coping skills and reducing stress among residents, reflected by changes in constructs such as emotional growth, perceived stress, optimism, and coping styles. Objective parameters (heart rate, galvanized skin response, sleep duration and quality, exercise and actigraphy) measured with the Basis health tracking device will help correlate objective signs to subjective report of stress.

Description:

The investigators adapted the Benson-Henry Institute Stress Management and Resiliency Training Program -- Relaxation Response Resiliency Program (SMART-3RP) to create the SMART-R resident wellness curriculum. The actual SMART-3RP is both a clinical program and research intervention. The three prongs of the SMART-R include 1) elicitation of the relaxation response through mind-body techniques 2) reducing overall stress reactivity and 3) increasing connectedness to self and others.

In a waitlist-control design, the SMART-R was implemented into multiple residents programs at Mass General Hospital, NYU Langone Medical Center, and Weill Cornell Medical College. The primary aim is to evaluate the effectiveness of the SMART-R in increasing coping skills and reducing stress among residents in the participating programs. Participants enrolled will be invited to complete 1) a brief questionnaire before, during (q3months) and after participation in the program (5 questionnaires total). The investigators will also collect continuous physiologic data using the Basis Peak Health Tracking device to correlate the physiologic data with self-report measures of stress.

Additionally, objective indicators of daily workload (page frequency, and quantity of notes authored by a resident during a given period) will help control for residents' schedules and busyness, in evaluating perceived stress, wellbeing and other outcomes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 173
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Residents in the following participating departments: departments of psychiatry, pediatrics, or neurology at MGH, medicine or psychiatry at NYU, or medicine or psychiatry at Cornell

Exclusion Criteria:

• Not a resident in the participating departments

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Resident Burnout

Intervention

Behavioral:
• Stress Management and Resiliency Training for Residents (SMART-R)
The Stress Management and Resiliency Training Program for residents (SMART-R) is a six-hour intervention delivered over 2 or 3 sessions that teaches residents mind-body skills to reduce stress and enhance coping strategies.

Locations

Country	Name	City	State
United States	MGH Benson-Henry Institute for Mind Body Medicine	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	New York University Langone Medical Center, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in burnout levels post intervention	Maslach Burnout Inventory (MBI), a validated 22-item self-report measure of professional burnout in human services. The MBI consists of 3 subscales of burnout: emotional exhaustion, depersonalization, and low sense of personal accomplishment.	change between baseline (July 2015), midpoint (week 25), to post intervention (week 52)	No
Secondary	Change in perceived stress post intervention	Perceived Stress Scale (PSS-10)	change between baseline (July 2015), midpoint (week 25), to post intervention (week 52)	No
Secondary	Change in continuous physiologic data throughout intervention	Basis Peak Health Tracking device collects continuous physiologic data (heart rate, galvanized skin response, sleep duration and quality, exercise and actigraphy)	change between baseline (July 2015), midpoint (week 25), to post intervention (week 52)	No
Secondary	change in mindfulness post intervention	Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)	change between baseline (July 2015), midpoint (week 25), to post intervention (week 52)	No